Tuesday, March 25, 2008

Useless Health Care

A while back, I noticed that I had seen several news stories about treatments or medications that turned out to be useless or even harmful. So I started keeping a file that I've been regularly updating (I'm aware, of course, that this could be seen as an exercise in confirmation bias).

The list has grown long enough that I'm putting it here for reference.

Yet, for all of the spending, they found people with spine problems actually felt worse.

"Healthcare expenditures for people with spinal problems have increased substantially -- 65% since 1997. Within that, we found pharmaceutical expenditures have increased 171%," said Brook Martin of the University of Washington in Seattle, whose study appears in the Journal of the American Medical Assn.

"If we are spending that much money on spine problems, we would expect to see improvements in the health of the population," Martin said in a telephone interview.

"What this study shows is we are not seeing commensurate improvements among people with spine problems."

Comparing resource inputs and outcomes among populations living in the 306 hospital referral regions . . . in the United States has been the focus of the Dartmouth Atlas Project. The studies consistently show that more resource inputs and utilization do not result in better outcomes. For example, in a recent study, researchers in the Dartmouth Atlas group examined outcomes for three patient cohorts: people who had had hip fractures, heart attacks, or colectomies for colon cancer. The patients were followed for up to five years after their initial events. The study's major finding was that regions with greater care intensity had increased mortality rates.

But in her persuasive Overtreated, Shannon Brownlee, a medical journalist and senior fellow at the New America Foundation, argues that too much medicine -- for many patients, much of the time -- is doing serious damage to the nation's health, while also costing us an arm and a leg. "We spend between one fifth and one third of our health care dollars . . . on care that does nothing to improve our health," she points out. Many treatments that have become widely accepted in recent years -- including proton pump inhibitors for ulcers, arthroscopic knee surgery for arthritis, hormone replacement therapy for menopause and high-dose chemotherapy for breast cancer -- "have ultimately been shown to be unnecessary, ineffective, more dangerous than imagined, or sometimes more deadly than the diseases they were intended to treat."

10. One recent study from the New England Journal of Medicine found that much so-called "preventive" care is not cost-justified.

11. Cholesterol drugs -- on which we spend billions every year -- may be much less effective than once thought, and what effectiveness they do have might be just from reducing inflammation in the way that aspirin does. Said Business Week:

James M. Wright, is no ordinary family physician. A professor at the University of British Columbia, he is also director of the government-funded Therapeutics Initiative, whose purpose is to pore over the data on particular drugs and figure out how well they work. Just as Winn started on his treatment, Wright's team was analyzing evidence from years of trials with statins and not liking what it found.

Yes, Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death. But Wright had a surprise when he looked at the data for the majority of patients, like Winn, who don't have heart disease. He found no benefit in people over the age of 65, no matter how much their cholesterol declines, and no benefit in women of any age.

He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials. But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization—despite big reductions in "bad" cholesterol. "Most people are taking something with no chance of benefit and a risk of harm," says Wright.

* * *

One dirty little secret of modern medicine is that many drugs work only in a minority of people. "There's a tendency to assume drugs work really well, but people would be surprised by the actual magnitude of the benefits," says Dr. Steven Woloshin, associate professor of medicine at Dartmouth Medical School.

A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people a week, failed to show that the drug has any medical benefits, Merck and Schering-Plough said on Monday. * * *

While Zetia lowers cholesterol by 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems.

This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew almost twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.

Part of the problem, Krumholz, Nissen and others say, is how the government sometimes evaluates drugs, relying on "surrogate endpoints" instead of medications' ability to treat or prevent illnesses. Cholesterol-lowering drugs, for example, can be approved based on their power to cut cholesterol and not on whether they protect against heart attacks or strokes. Diabetes drugs can be approved based on whether they reduce a protein known as hemoglobin A1C -- a measure of blood sugar -- and not on their effect on complications caused by high blood sugar.

"There are a lot of things we do in this country where we treat these surrogate measures with very little evidence that we are actually treating the patient," said Nortin M. Hadler, a professor of medicine at the University of North Carolina.

If one drug prevents heart attacks by lowering cholesterol, that does not guarantee that another will do the same if it works differently, critics argue. And drugs may have unforeseen hazards that outweigh any benefits, or they may not produce secondary effects, such as lowering inflammation, that add to their usefulness.

Take Avandia, GlaxoSmithKline's (GSK) drug for preventing the deadly progression of diabetes. The blockbuster, with $2.6 billion in U.S. sales in 2006, made headlines in 2007 when an analysis of clinical trial data showed it increased the risk of heart attacks. The largely untold story: There's little evidence the drug actually helps patients. Yes, Avandia is very good at lowering blood sugar, just as statins lower cholesterol levels. But that doesn't translate into preventing the dire consequences of diabetes, including heart disease, strokes, and kidney failure. Clinical trials "failed to find a significant reduction in cardiovascular events even with excellent glucose control," wrote Dr. Clifford J. Rosen, chair of the Food & Drug Administration committee that evaluated Avandia, in a recent commentary in The New England Journal of Medicine. "Avandia is almost the poster child for everything wrong with our system," says UCLA's Hoffman.

3 Comments:

Isn't the proliferation of useless drugs and surgeries be inevitable consequences of a for-profit health care system? I write this as I look over a Wall Street Journal article (link by subscription only) that describes how Schering-Plough and Merck are "mounting an aggressive campaign to defend their $5 billion a year franchise for cholesterol drugs Vytorin and Zetia against calls from leading cardiologists to curtail the drugs' use." Page B1, 4/1/08.

Interestingly, the recommendation to curtail usage is based on a study showing that Vytorin and Zetia are no better than cheaper statins at arresting the progress of disease in neck arteries, which the study treats as a proxy for the effectiveness of these drugs. Based on some of your links, it appears that the statins, Vytorin and Zetia may all be equally useless for actually preserving or enhancing the health of those who use them. But at least the statins cost less.